Variola Virus Nucleic Acid-Based Detection Assay
PRA is the FDA product code for Variola Virus Nucleic Acid-Based Detection Assay, a class II device type, regulated under 21 CFR 866.3316. FDA's definition for this code reads: "The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PRA
- Device name
- Variola Virus Nucleic Acid-Based Detection Assay
- FDA definition
- The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.
- Regulation
- 21 CFR 866.3316
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PRA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
Applicants with the most clearances
Product code PRA| Applicant | Clearances |
|---|---|
| Centers for Disease Control and Prevention (CDC) | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.